MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number 1039362

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 11/16/2017

Event Type  Injury  

Event Description

The manufacturer received a voluntary medwatch, mw5073861, alleging a nasal cannula being used with an everflo oxygen concentrator caught fire while the patient was cooking on an electric stove.The patient received burns to her face and was admitted to the hospital 3 days later.The device is not returning to the manufacturer for evaluation.The durable medical equipment (dme) supplier stated there was no evidence of damage to the device.The dme tested the device and the device passed all testing and was placed back in the field.Product labeling states,"oxygen vigorously accelerates combustion and should be kept away from heat or open flame.Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.Do not smoke, allow others to smoke or have open flames near the concentrator when it is in use.".

Manufacturer Narrative

The manufacturer previously reported the date of the event and date of the report as (b)(6) 2018.The correct date of the event and date of the report is (b)(6) 2018.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• Manufacturer (Section G): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• Manufacturer Contact: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 7168575
• MDR Text Key: 96515255
• Report Number: 1040777-2018-00001
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032668
• UDI-Public: 00606959032668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1039362
• Device Catalogue Number: 1039362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR